TalarLift STS
K-Number: K170624 · 2017-08-11
ApplicantFusion Orthopedics, LLC
Decision Date2017-08-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TalarLift STS is a medical device manufactured by Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2017-08-11 under approval number K170624. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TalarLift STS?
TalarLift STS is a medical device that received FDA 510(k) clearance on 2017-08-11. It is manufactured by Fusion Orthopedics, LLC. The 510(k) number is K170624.
When was TalarLift STS approved by the FDA?
TalarLift STS received FDA 510(k) clearance on 2017-08-11, under approval number K170624.
What company makes TalarLift STS?
TalarLift STS is manufactured by Fusion Orthopedics, LLC.
What is the FDA product code for TalarLift STS?
The FDA product code for TalarLift STS is HWC. This falls under the Cardiovascular category.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.